2. Academic Validation
  3. A preliminary study on the safety and efficacy of 177Lu-FAP-2286 in gastrointestinal tumours with positive FAP expression

A preliminary study on the safety and efficacy of 177Lu-FAP-2286 in gastrointestinal tumours with positive FAP expression

  • Radiother Oncol. 2025 Oct 4:213:111195. doi: 10.1016/j.radonc.2025.111195.
Xuecheng Bai 1,  Na Zhang 2,  Hong Liu 3,  Yang Xie 2,  Benjian Gao 1,  Tingting Xu 2,  Zhiqiao Liu 2,  Peng Wang 2,  Wenlu Zheng 2,  Xiaoli Yang 1,  Yue Chen 4,  Bo Li 5
Affiliations

Affiliations

  • 1 Department of General Surgery (Hepatopancreatobiliary Surgery), The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Academician(Expert) Workstation of Sichuan Province, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China.
  • 2 Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Institute of Nuclear Medicine, Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China.
  • 3 Department of General Surgery (Hepatopancreatobiliary Surgery), The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Academician(Expert) Workstation of Sichuan Province, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Department of Hepatobiliary and Pancreatic Surgery, Dazhou Central Hospital, 635000 Sichuan, People's Republic of China.
  • 4 Department of Nuclear Medicine, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Institute of Nuclear Medicine, Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China. Electronic address: chenyue5523@126.com.
  • 5 Department of General Surgery (Hepatopancreatobiliary Surgery), The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Academician(Expert) Workstation of Sichuan Province, The Affiliated Hospital of Southwest Medical University, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China; Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, No. 25 Taiping St, Jiangyang District, Luzhou 646000 Sichuan, People's Republic of China. Electronic address: liboer2002@126.com.
PMID: 41052603 DOI: 10.1016/j.radonc.2025.111195
Abstract

Background and purpose: Preclinical studies of fibroblast activation protein (FAP)-2286 showed improved tumor-targeting specificity and prolonged intratumoral retention. However, clinical trials on the safety and efficacy of 177Lu-FAP-2286 for gastrointestinal tumors are limited. This study aims to evaluate its safety and efficacy in patients with FAP-positive gastrointestinal tumors.

Materials and methods: A prospective, single-center, single-arm clinical trial was conducted at the Affiliated Hospital of Southwest Medical University from December 2020 to December 2024. After confirming FAP expression in tumor lesions using 68Ga-FAP-2286, 177Lu-FAP-2286 targeted radiotherapy was performed. Tumor response was assessed using RECIST 1.1 and PERCIST 1.0 criteria. Adverse events were graded according to the CTCAE 5.0.

Results: Fourteen participants (mean age, 62.1 ± 7.6 years) completed 30 treatment cycles. Four participants (28.6 %) achieved stable disease, and ten (71.4 %) exhibited progressive disease. The disease control rate was 28.6 %. No significant correlations were found between clinical efficacy and imaging parameters. No grade III or IV adverse events occurred, but transient nausea, vomiting, and diarrhea were observed.

Conclusions: 177Lu-FAP-2286 demonstrated good feasibility and safety in treating FAP-positive gastrointestinal tumors, resulting in disease stabilization in a subset of patients.

Keywords

(177)Lu-FAP-2286; FAP; Gastrointestinal tumours; TRT.

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